Rad-57 Signal Extraction Pulse CO-Oximeter Operators Manual Feb 2016

The Rad-57 Signal Extraction Pulse CO-Oximeter Operating Instructions intend to provide the necessary information for proper operation of all Rad-57 Pulse CO-Oximeter models. General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Rad-57 Signal Extraction Pulse CO-Oximeter models are prerequisites for proper use. Do not operate any of the Rad-57 Signal Extraction Pulse CO-Oximeter models without completely reading and understanding these instructions. NOTICE Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION:

FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. For further information contact: Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU Authorized Representative for Masimo Corporation:

EC

REP

MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

Covered by one or more of the following U.S patents: 5482036, 5490505, 5632272, 5685299, 5758644, 5769785, 5919134, 6002952, 6011986, 6067462, 6157850, 6229856, 6236872, 6263222, 6360114, 6388240, 6430525, 6463311, 6501975, 6515273, 6606511, 6643530, 6650917, 6654624, 6684090, 6699194, 6745060, 6816741, 6826419, 6850787, 6861639, 6979812, 7186966, 7215984, 7215986, 7221971, 7254433, 7295866, 7328053, 7373194, 7376453, 7377899, 7467002, 7469157, 7471969, 7489958, 7496393, 7499741, 7509154, 7530955, RE38476, RE38492, international equivalents, or one or more of the patents referenced at www. masimo.com/patents.htm. Other patents pending. © 2016 Masimo Corporation. Masimo, , SET, Rad, LNCS, LNOP, Signal IQ, Discrete Saturation Transform, DST, Rainbow, SpCO,SpMet, and FastSat are registered trademarks of Masimo Corporation. Rad-57, SIQ, LNOPv, Pulse CO-Oximeter and APOD are trademarks of Masimo Corporation.

CONTRAINDICATIONS: The Rad-57 is contraindicated for use as an apnea monitor. Safety Information, Warnings and Cautions The Rad-57™ is designed to minimize the possibility of hazards from errors in the software program by following Sound Engineering Design Processes, Risk Analysis and Software Validation. ■ The Rad-57 is to be operated by qualified personnel only. This manual, accessories, Directions for Use, all precautionary information, and specifications should be read before use. ■ Explosion hazard. Do not use the Rad-57 in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. ■ Electric shock hazard. Do not open the Rad-57 cover except to replace the batteries. Only a qualified operator may perform maintenance procedures specifically described in this manual. Refer servicing to Masimo for repair of this equipment. ■ High intensity extreme lights (such as pulsating strobe lights and direct sunlight) directed on the sensor, may not allow the Rad-57 to obtain readings. ■ EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause errors or incorrect measurements on the Rad-57. ■ If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to completely understand the patient's condition. ■ Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The Rad-57 should not be used as a replacement or substitute for ECG based arrhythmia analysis. ■ As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. ■ Do not place the Rad-57 or accessories in any position that might cause it to fall on the patient. ■ Do not lift the Rad-57 by the patient cable or sensor. ■ Patient Safety - If a sensor is damaged in any way, discontinue use immediately. ■ Rad-57 should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms. ■ Always remove the sensor from the patient and completely disconnect the patient from the Rad57 before bathing the patient. ■ Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. ■ Do not use the Rad-57 or sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The Rad-57 may affect the MRI image, and the MRI device may affect the accuracy of the Pulse CO-Oximetry parameters and measurements. ■ Do not use the Rad-57 during electrocautery. ■ Do not use the Rad-57 or sensor during defibrillation. ■ If using the Rad-57 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the instrument might read zero for the duration of the active irradiation period. Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Safety Information, Warnings and Cautions, continued

■ Do not place the Rad-57 where the controls can be changed by the patient. ■ Do not place the Rad-57 on electrical equipment that may affect the instrument, preventing it from working properly. ■ Do not expose the Rad-57 to excessive moisture such as direct exposure to rain. Excessive moisture can cause the instrument to perform inaccurately or fail. ■ Do not place containers containing liquids on or near the Rad-57. Liquids spilled on the instrument may cause it to perform inaccurately or fail. ■ Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment ■ SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The Rad-57 cannot measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement. ■ Inaccurate SpO2 readings can be caused by: z

Improper sensor placement

z

Elevated levels of COHb and MetHb

z

For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present.

z

NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.

■ For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.

■ Inaccurate SpCO and SpMet readings can be caused by: z Improper sensor application z Intravascular dyes such as indocyanine green or methylene blue z Abnormal hemoglobin levels z Low arterial perfusion z Low arterial oxygen saturation levels including altitude induced hypoxemia z Elevated total bilirubin levels z Motion artifact z SpCO readings may not be provided if SpO2 readings are less than 90% z SpCO readings may not be provided if SpMet readings are greater than 2% z Intravascular dyes such as indocyanine green or methylene blue ii

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Safety Information, Warnings and Cautions, continued

z Externally applied coloring (such as nail polish) z Elevated levels of bilirubin z Severe anemia z Low arterial perfusion z Motion artifact ■ Do not place the Rad-57 against a surface or cover the speaker. This can cause the system or battery (non clinical) alarm to be muffled. ■ If the Rad-57 fails any part of the setup procedures remove the instrument from operation until qualified service personnel have corrected the situation. ■ Use the Rad-57 in accordance with Section 7, Environmental Specifications in of this manual. ■ Do not incinerate batteries. ■ To protect against injury from electric shock, follow the directions below: ■

Avoid placing the device on surfaces with visible liquid spills.

■

Do not soak or immerse the device in liquids.

■

Use cleanings solutions sparingly.

■ This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ■ This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. ■ In accordance with international telecommunication requirements, the frequency band of 5,150 MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.

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Safety Information, Warnings and Cautions, continued

■ This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. ■ A functional tester cannot be utilized to assess the accuracy of the Rad-57 or any sensors. ■ Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the FDA, or in any manner inconsistent with the instructions for use or labeling. The device and related accessories are not intended for use in combination with other medical devices or in highrisk applications. ■ Disposal of product - Comply with local laws in the disposal of the instrument and/or its accessories. ■ This Class B digital apparatus complies with Canadian ICES-003.

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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Table of Contents Safety Information, Warnings and Cautions...i SECTION 1 - OVERVIEW About this Manual... 1-1 Warnings, Cautions and Notes... 1-2 Product Description... 1-3 Features and Benefits...1-3 Indications for Use...1-4 Pulse CO-Oximetry... 1-5 SpO2 General Description...1-5 SpCO General Description...1-6 SpMet General Description...1-6 Pleth Variability Index - (PVI) General Description...1-6 Low Perfusion...1-6 FastSat...1-7 SmartTone ...1-7 Principles of Operation...1-8 Functional vs. Fractional Saturation...1-9 Rad-57 vs. Drawn Whole Blood Measurements...1-9 Masimo SET Signal Extraction Technology For SpO2 Measurements...1-9 SpMet, and SpCO Measurements During Patient Motion...1-9 Masimo Rainbow SET Parallel Engines...1-10 Masimo SET DST®...1-10 SECTION 2 - SYSTEM DESCRIPTION Introduction... 2-1 Rad-57 Front Panel Controls... 2-2 Rad-57 Rear Panel ... 2-4 Battery Installation...2-4 Symbols...2-5 SECTION 3 - SETUP Introduction... 3-1 Unpacking and Inspection... 3-1 Preparation for Monitoring... 3-1 Monitor Setup... 3-2 Initial Setup...3-2 SECTION 4 - OPERATION Introduction... 4-1 Basic Operation... 4-1 General Setup and Use...4-1 Default Settings...4-3 Successful SpO2 Monitoring... 4-5 Masimo Sensors...4-5 Numeric Display - SpO2...4-5 Numeric Display - Pulse Rate ...4-6 Numeric Display - SpCO (upgraded Instrument)...4-7 Numeric Display - SpMet (upgraded Instrument)...4-7 Numeric Display - PI ...4-8 Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Table of Contents Pleth Variability Index - PVI (upgraded Instrument)...4-8 Low Signal IQ (Low SIQ)...4-8 Low Perfusion...4-8 Actions to be Taken...4-9 Sensitivity...4-9 Battery Level Indicator...4-10 Low Battery Audible Alarm...4-10 Normal Patient Monitoring...4-11 Rad-57 Front Panel Control Operation... 4-11 Setup Menu...4-11 Menu Navigation... 4-11 Setup Menu Level 1 – Alarm Volume and Alarm Silence...4-12 Setup Menu Level 2 – Alarm Limits...4-12 Setup Menu Level 3 – Sensitivity, Averaging, FastSat, SmartTone...4-13 Setup Menu Level 4 - Trend Settings...4-14 Setup Menu Level 5 - LED Brightness and Factory Defaults...4-15 Menu Selection...4-15 Power Off...4-15 Special Menu... 4-16 Special Menu – Line Frequency Configuration...4-16 Trend Setup and Use... 4-17 Introduction...4-17 TrendCom Utility Installation...4-17 Erasing Trend Memory...4-17 Trend Data Format...4-17 SECTION 5 - ALARMS AND MESSAGES Alarm Indication... 5-1 Alarm Limits... 5-1 Alarm Silence...5-3 Alarm Silenced Indicator...5-3 Messages...5-4 SECTION 6 - TROUBLESHOOTING Troubleshooting... 6-1 SECTION 7 - SPECIFICATIONS Rad-57 Specifications... 7-1 Performance...7-1 Electrical...7-2 Environmental...7-2 Physical Characteristics...7-2 SECTION 8 - SENSOR AND PATIENT CABLES Introduction... 8-1 Selecting a Sensor...8-1 Sensor Application Instructions...8-1 Masimo Rainbow® Sensors...8-2 Rainbow R Series Adhesive Sensors...8-2

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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Table of Contents Rainbow Adhesive Sensors...8-2 Rainbow Direct Connect Sensors...8-3 Rainbow Reusable Sensors...8-3 Rainbow Resposable™ Pulse CO-Oximeter Sensor System...8-3 Masimo SpO2 Sensors...8-4 Red Reusable Sensors ...8-4 ® LNOP Reusable Sensors ...8-4 ® LNOP Adhesive Sensors ...8-4 ® LNOP Specialty Sensors ...8-5 M-LNCS™/LNCS® Reusable Sensors ...8-5 M-LNCS™/LNCS® Adhesive Sensors ...8-5 M-LNCS™/LNCS® Specialty Sensors...8-6 TM LNOPv Adhesive Sensors ... 8-6 Sensor Accuracy...8-6 Cleaning And Reuse Of Masimo Reusable Sensors and Cables...8-6 Reattachment of Single Use Adhesive Sensors...8-6 SECTION 9- SERVICE AND MAINTENANCE Introduction... 9-1 Cleaning... 9-1 Battery Replacement...9-2 Performance Verification... 9-2 Power-On Self-Test...9-2 Key Press Button Test...9-2 Alarm Limit Test...9-3 LED Brightness...9-3 Service and Repair... 9-3 Repair Policy...9-3 Return Procedure...9-3 Sales & End-user License Agreement... 9-5 Warranty... 9-5 Exclusions... 9-5 End-User License ... 9-6 Restrictions... 9-6 SECTION 10- ACCESSORIES Accessories... 10-1

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

1

About this Manual This manual explains how to set up and use the Rad-57 Instrument Signal Extraction Pulse CO-Oximeter. Important safety information relating to general use of the Rad-57 appears before this introduction. Other important safety information is located throughout the manual where appropriate. Read the entire safety information section before you operate the monitor. In addition to the safety section, this manual includes the following sections: SECTION 1

Overview gives a general description of Pulse CO-Oximetry.

SECTION 2

System Description describes the Rad-57 system, functions and features.

SECTION 3  Setup describes how to setup the Rad-57 for use. SECTION 4

Operation describes the operation of the Rad-57.

SECTION 5

Alarms and Messages describes the alarm system messages.

SECTION 6

Troubleshooting gives troubleshooting information.

SECTION 7

Specifications gives the detailed specifications of the Rad-57.

SECTION 8

Sensors and Patient Cables outlines how to use and care for Masimo sensors and patient cables.

SECTION 9

Service And Maintenance describes how to maintain, service and obtain repair for the Rad-57.

SECTION 10 Accessories

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

1 Warnings, Cautions and Notes

Please read and follow any warnings, cautions and notes presented throughout this manual. An explanation of these labels are as follows: A WARNING is provided when actions may result in a serious outcome (i.e., injury, serious adverse affect, death) to the patient or user. Look for text in a gray shaded box. Sample of Warning: WARNING: THIS IS A SAMPLE OF A WARNING STATEMENT.

A CAUTION is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this instrument or damage to other property. Sample of Caution: CAUTION: THIS IS A SAMPLE OF A CAUTION STATEMENT. A NOTE is provided when additional general information is applicable. Sample of Note: NOTE: This is a sample of a Note.

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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

1

Product Description The Rad-57 Handheld Pulse CO-Oximeter with Masimo Rainbow® SET® Technology is a noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-57 features a multicolored LED display that continuously displays numeric values for SpO2, Perfusion Index (PI) and pulse rate (PR), a Low Signal IQ Indicator (Low SIQ) indicator, alarm status, alarm silence and battery life. After upgrading, Carboxyhemoglobin saturation (%SpCO), Methemoglobin percentage (%SpMet), and Pleth Variability Index (PVI™) can display if the corresponding sensors are attached. When upgrading the Instrument, follow the upgrade procedures as described in the "Field Upgrader Tool" Directions for Use, part number 31650. The following list outlines the key features and benefits of the Rad-57 Handheld Pulse CO-Oximeter. Features and Benefits ■ Clinically proven Masimo SET® technology performance ■ Proven for accurate SpO2 and pulse rate monitoring in motion and low perfusion environments ■ SpO2, pulse rate, Perfusion Index, Pleth Variability Index (PVI)*, carboxyhemoglobin (% SpCO)* and methemoglobin (SpMet)* displays ■ Low Signal IQ (SIQ™) indicator ■ Lightweight, convenient handheld design ■ Over 8 hours of continuous use on 4 AA alkaline batteries ■ Visual battery life indicator ■ Audible Alarm for sensor-off and low battery ■ Alarms for SpO2, PR, SpCO* and SpMet*, PVI* ■ FastSat® (for SpO2 measurement) ■ Three sensitivity levels - Max, Normal and APOD™ (for SpO2 measurement) ■ 72 hours of trending memory ■ Adjustable alarm volume ■ Adjustable averaging 2 to 16 seconds * available in upgraded Instrument

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

1

Indications for Use The Masimo SET® Rad-57 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and carboxyhemoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. * available in upgraded Instrument

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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

1

Pulse CO-Oximetry SpO2 General Description Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects to the pulse oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in two ways: 1) As a percent value for arterial oxygen saturation (SpO2) 2) As a pulse rate (PR) The following figure shows the general monitoring setup.

3

1. Instrument 2. Sensor 3. Patient Cable 1

2

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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1

Overview SpCO General Description Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of carbon monoxide concentration (SpCO) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpCO measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through an instrument patient cable. The sensor collects signal data from the patient and sends it to the instrument. The Rad-57 displays the calculated data as percentage value for the SpCO, which reflect blood levels of carbon monoxide bound to hemoglobin. SpMet General Description Pulse CO-Oximetry is a continuous and non-invasive method of measuring the levels of methemoglobin concentration (SpMet) in arterial blood. It relies on the same basic principles of pulse oximetry (spectrophotometry) to make its SpMet measurement. The measurement is obtained by placing a sensor on a patient, usually on the fingertip for adults and the hand or foot for infants. The sensor connects either directly to the Pulse CO-Oximetry instrument or through an instrument patient cable. The sensor collects signal data from the patient and sends it to the instrument. The Rad-57 displays the calculated data as percentage value for the SpMet. Pleth Variability Index - (PVI) General Description The Pleth Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percentage (0-100%). Low Perfusion It has been suggested that at extremely low perfusion levels, Pulse CO-Oximeters can measure peripheral saturation, which may differ from central arterial saturation. This “localized hypoxemia” may result from the metabolic demands of other tissues extracting oxygen proximal to the measurement site under conditions of sustained peripheral hypoperfusion. (This may occur even with a pulse rate that correlates with the ECG heart rate.) CAUTION: IF LOW PERFUSION IS FREQUENTLY INDICATED, FIND A BETTER-PERFUSED MONITORING SITE. IN THE INTERIM, ASSESS THE PATIENT AND, IF INDICATED, VERIFY OXYGENATION STATUS THROUGH OTHER MEANS.

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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

1

FastSat FastSat enables rapid tracking of arterial oxygen saturation changes. Arterial oxygen saturation data is averaged using pulse oximeter averaging algorithms to smooth the trend. When the Rad-57 is set to FastSat “On”, the averaging algorithm evaluates all the saturation values providing an averaged saturation value that is a better representation of the patient’s current oxygenation status. With FastSat, the averaging time is dependent on the input signal. SmartTone The SmartTone feature uses a proprietary algorithm that will provide pulse tones during excessive motion and low perfusion conditions. The pulse tone is based on an averaged pulse rate measurement from the proprietary algorithm and may not identify irregular heart beat patterns when there is excessive artifact present. The Normal Tone feature uses a proprietary algorithm that will provide pulse tones during non motion and adequate perfusion conditions. In this mode, the pulse tone may not sound if excessive artifact is present.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

1 Principles of Operation Pulse oximetry is governed by the following principles:

1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry, see figure below). Absorption Spectra 4.0

Carboxyhemoglobin

3.5

Oxyhemoglobin Methemoglobin

Absorption (1/mm)

Deoxyhemoglobin

3.0

Plasma

2.5 2.0 1.5 1.0

GR-13315

0.5

GRAPHIC DOCUMENTATION AND APPRO VAL 0 600

Approvals Kevin McHale

800 Approvals

Date

1000

1200

DRO-10430 1400

1600

Wavelength (nm)

Marketing Communications

Date

10/5/04 2. The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

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Title

13315

Graphic, LED/Photo Detector Placment

Program

The Rad-57 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between oxygenated Adobe Illustrator 10.0 (.eps) blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma. The Rad-57 utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the site to a photodiode (detector). See figure below. Signal data is obtained by passing various visible and infrared lights (LED’s, 500 to 1000nm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle. This information may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25mW. The detector receives the light, converts it into an electronic signal and sends it to the Rad-57 for calculation. 1

2

1. Light Emitting Diodes (LEDs) (7 + wavelengths) 2. Detector

Once the Rad-57 receives the signal from the sensor, it utilizes Masimo Rainbow SET signal extraction technology to calculate the patient’s functional oxygen saturation (%SpO2), blood levels of carboxyhemoglobin (SpCO*), methemoglobin (SpMet*) and pulse rate. The SpCO and SpMet measurements rely on a multiwavelength calibration equation to quantify the percentage of: carbon monoxide or methemoglobin in arterial blood. The maximum of the skin surface temperature is measured at an ambient temperature of less than 106º F (41º C). This is verified by Masimo sensor skin temperature test procedures. *available in upgraded Instrument

DENTIAL AND PROPRIETARY Masimo Corporation hts Reserved

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Page 1 of 1 FRM 1379 Rev A DRO 5201

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

Overview

1

Functional vs. Fractional Saturation The Rad-57 is calibrated to measure and display functional saturation (SpO2): the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen. Note that carboxyhemoglobin is not capable of transporting oxygen, but is recognized as oxygenated hemoglobin by conventional pulse oximetry. Rad-57 vs. Drawn Whole Blood Measurements When SpO2, SpCO, and SpMet measurements obtained from the Rad-57 (noninvasive) are compared to drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry methods, caution should be taken when evaluating and interpreting the results. The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2, SpCO, and SpMet measurements of the Rad-57 Pulse COOximeter. In the case of SpO2, different results are usually obtained from the arterial blood gas sample if the calculated measurement is not appropriately corrected for the effects of variables that shift the relationship between the partial pressure of oxygen (PO2) and saturation, such as: pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. In the case of SpCO, different results are also expected if concentration of methemoglobin in the blood gas sample is elevated. High levels of bilirubin may cause erroneous SpO2, SpMet, and SpCO readings. As blood samples are usually taken over a period of 20 seconds (the time it takes to draw the blood) a meaningful comparison can only be achieved if the oxygen saturation, carboxyhemoglobin and methemoglobin concentration of the patient are stable and not changing over the period of time that the blood gas sample is taken. Subsequently, blood gas and laboratory COOximetry measurements of SpO2, SpCO, and SpMet may vary with the rapid administration of fluids and in procedures such as dialysis. Additionally, drawn, whole-blood testing can be affected by sample handling methods and time elapsed between blood draw and sample testing. Masimo SET Signal Extraction Technology For SpO2 Measurements Masimo Signal Extraction Technology’s signal processing differs from conventional pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood moving (pulsating) in the measurement site. During patient motion, however, the non-arterial blood also moves, causing conventional pulse oximeters to read low values, because they cannot distinguish between the arterial and venous blood movement (sometimes referred to as noise). Masimo SET pulse oximetry utilizes parallel engines and adaptive digital filtering. Adaptive filters are powerful because they are able to adapt to the varying physiologic signals and/or noise and separate them by looking at the whole signal and breaking it down to its fundamental components. The Masimo SET signal processing algorithm, Discrete Saturation Transform® (DST)®, reliably identifies the noise, isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen saturation for display on the monitor. SpMet, and SpCO Measurements During Patient Motion The Rad-57 displays measurements of SpCO* and SpMet* during patient motion. However, because of the changes in the physiological parameters such as blood volume, arterial-venous coupling, etc. that occur during patient motion, the accuracy of such measurements may not be reliable during excessive motion. When the Rad-57 does not have confidence in the value of a parameter due to poor signal quality caused by excessive motion or other signal interference, the Low Signal IQ (Low SIQ) LED will flash. *available in upgraded Instrument

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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Overview

1

Masimo Rainbow SET Parallel Engines This figure is for conceptual purposes only.

12

FST

MST

Masimo SET DST®

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Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

System Description

2

Introduction The Rad-57 is a full featured Pulse CO-Oximeter designed for ease of operation. All pulse oximetry measurement information, as well as instrument status data, is displayed on the front panel of the instrument. All user input is handled by control buttons on the front panel and the sensor cable connection is located at the top edge of the instrument. The Rad-57 is powered by 4 AA alkaline batteries, which provides a minimum of 8 hours of battery life. ■ Rad-57 offers full Masimo Rainbow SET Technology in a small, hand held instrument. ■ Rad-57 supports the full line of Masimo sensors (see Section 8, Sensors and Patient Cables). ■ Provides 72 hours of trending memory. A Direct Connect Rainbow reusable sensor or patient cable or a Direct Connect Red reusable sensor or patient cable attaches to the patient cable connector on the top of the Rad-57 Instrument. The Rad57 can be used either as a transport monitor or as a handheld Pulse CO-Oximeter for spot checks.

Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual

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